Showing posts with label Bioethics. Show all posts
Showing posts with label Bioethics. Show all posts

Wednesday, January 23, 2013

Dr. David Healy: Psychotropic Drugs Cause Violent Behavior

via WND:
Top Psychiatrist: Meds Behind school Massacres
Society conducting 'vast social experiment' without knowing its end


by JEROME R. CORSI 

If lawmakers and authorities are truly concerned about stopping gun violence in schools, they need to take a close look at the prescription of psychotropic drugs for children and young people, says a leading psychiatrist.

In an exclusive in-person interview in New York City with WND, London-based Dr. David Healy criticized pharmaceutical companies that have made billions of dollars marketing Selective Serotonin Reuptake Inhibitors, known as SSRIs.

Psychotropic drugs “prescribed for school children cause violent behavior,” Healy stated.

The drugs are widely used in the U.S. as antidepressants by doctors working in the mental health field and increasingly by primary care doctors, he noted.

Healy insisted the problem today is that doctors working with schools to control the behavior of children are inclined to prescribe SSRI drugs without serious consideration of adverse consequences.

“The pharmaceutical companies made these drugs with the idea of making money,” he said. “There’s a wide range of problems when it comes to looking at these drugs for children. Very few children have serious problems that warrant treatment with pills that have the risks SSRI drugs have.”

The drugs can make children “aggressive and hostile,” he noted.

“Children taking SSRI drugs are more likely to harm or to injure other children at school,” said Healy. “The child may be made suicidal.

“We are giving drugs to children who are passing through critical development stages, and as a society we are really conducting a vast experiment and no one really knows what the outcome of that will be.”

Healy cautioned that there is a very high correlation between mass shootings and use of the drugs.

“When roughly nine out of every 10 cases in these school shootings and mass shootings involve these drugs being prescribed, then at least a significant proportion of these cases were either caused by the drugs or the drugs made a significant contribution to the problem,” he said.

President Obama, in a series of 23 presidential memoranda and proclamations signed last week, called for the Centers for Disease control to undertake research to examine gun violence and to explore medical means to control the problem.

WND contended that putting more mental illness screening into schools would actually increase the incidence of school shootings, not reduce the violence.

“You can draw a line between the number of child psychiatrists in the United States and the number of school shootings, and you will find that both have gone up in the same direction at the same time,” he said.

He sees a “propaganda campaign” being conducted in the U.S. in the wake of the Aurora, Colo., cinema shooting and the Newtown, Conn., school shooting asserting gun violence is being caused by mental illness and could be stopped by additional school programs that screen for it.

“If school children are screened for mental illness problems, this presumably will lead more medical doctors to put more students on more pills,” he said. “I would predict then the outcome of more school screenings for mental illness will be more mass killings, even if the guns are taken away and the mass killings are not done with guns.”



He cautioned shareholders of pharmaceutical companies to realize share prices can be adversely affected should judges and juries determine the companies bear legal liabilities. Law enforcement investigators could conclude one of the company’s medications was prescribed to a child who ended up perpetrating a school shooting.

Healy cautioned that medical doctors who prescribe pills do not necessarily cure mental illness problems.

Dr. David Healy
He argued that today medical doctors are inclined to solve a wide range of health problems by prescribing drugs. In previous generations, however, extended families were capable of providing a context of family history to understand behavioral problems and to identify a wide range of problem-solving treatments. The families understood the issue as a developmental problem better treated by family intervention than by medicine.
Read more at WND.com


Friday, October 19, 2012

Children being medicated for behavioral problems is a moral issue


Marianna, Kahlil's Sister
Marianna, Kahlil's Sister. Painting by Kahlil Gibran
Kahlil Gibran             
On Children
Your children are not your children.
They are the sons and daughters of 
Life's longing for itself.
They come through you but not from you,
And though they are with you yet they belong not to you.
You may give them your love but not your thoughts,
For they have their own thoughts.
You may house their bodies but not their souls,
For their souls dwell in the house of tomorrow,
which you cannot visit, not even in your dreams.
You may strive to be like them,
but seek not to make them like you.
For life goes not backward nor tarries with yesterday.
You are the bows from which your children
as living arrows are sent forth.
The archer sees the mark upon the path of the infinite,
and He bends you with His might
that His arrows may go swift and far.
Let your bending in the archer's hand be for gladness;
For even as He loves the arrow that flies,
so He loves also the bow that is stable.


The proliferation of psychotropic drugs prescribed to alter children's behavior, is something that must be drastically reduced, at the very least.  Karim aptly calls this practice, "meducating our children," in a recent article on Somatosphere about children without ADD or ADHD who are being prescribed amphetamines to enhance school performance. It is deeply disturbing how carelessly teratogenic drugs that have harmful adverse effects are being used. Even worse, the right to prescribe the drugs off label is being vehemently defended by psychiatrists. Apparently, defending a right that is being abused with impunity is more important than helping those patients who are harmed or calling for a stop to off label prescriptions which are not supported with empirical data, drugs prescribed for no valid medical reason.  If patients and the ethical prescribing practices are important, they are obviously not as important as maintaining the illusion of psychiatry, i.e. the drugs effectively and safely treat symptoms of whatever psychiatric diagnosis they have been given, if they have been given a diagnosis... 

Most of the off label prescriptions for poor children on Medicaid and are paid for illegally by fraudulently billing the cost of the drugs to Medicaid. It is an ongoing fraud, that no one, (that I know of) except for Jim Gottstein, of the Law Project for Psychiatric Rights has put any effort into stopping. The American taxpayers are footing the bill for drugs being prescribed off label, i.e. a non-FDA approved, to poor children on Medicaid. In reality, when there is no ethically valid medical reason for the prescription to be written, it is not medical treatment; it is unethical medical experimentation.  

It is simply immoral.



The online program to learn about psychotropic drugs for people who work with children Critical Think Rx, at the School of Social Work at Florida International University: here.

via Somatosphere
Meducating Our Children: The Moral Influence of Adderall on Education, Parenting, and Treatment
By Tazin Karim

"Allan Schwarz’s recent New York Times article “Attention Disorder or Not, Pills to Help in School” presented some controversial testimonials on the prescription of attention deficit and hyperactivity (ADHD) medications to low-income children. As science writer Emily Willingham points out, this article is part of a two decade long debate over the merits of medicating our nation’s children..." read here.

Somatosphere on twitter

Tazin Karim on twitter

Friday, September 21, 2012

Standard Mal-Practice in Psychiatry


“ . . . No one is really paying attention to what’s going on. . . The issue is how many Medicaid kids are being drugged to death, not how many kids in fostercare are being over medicated."
Grace E. Jackson, M.D., Author: Rethinking Psychiatric Drugs: A Guide for Informed Consent
and Drug-Induced Dementia: A Perfect Crime

via Newswise:

National Study Cites Increased Off Label Antipsychotic Drug Use Among Children

Released: 9/10/2012 9:15 AM EDT
Source: Children's Hospital of Philadelphia
Newswise — Philadelphia ⎯ A national study conducted by researchers at The Children’s Hospital of Philadelphia (CHOP) shows increased use of powerful antipsychotic drugs to treat publicly insured children over the last decade. The study, published today in the journal Health Services Research, found a 62 percent increase in the number of Medicaid-enrolled children ages 3 to 18 taking antipsychotics, reaching a total of 354,000 children by 2007.

Increased antipsychotic use was observed across a wide range of mental health diagnoses, and was particularly high for children with ADHD or conduct disorder, although the FDA has not approved the drugs to treat these conditions in children. In total, 65% of children prescribed antipsychotics in 2007 were using the drugs “off-label,” or without FDA safety and efficacy data to support their use to treat young patients. The CHOP study is the second released this month that focuses on the use of antipsychotic drug use in children and is largest of its kind, representing 35% of children in the country.

“Given the significant proportion of off-label use of antipsychotics in children, it is reassuring that these drugs have been recognized as a priority for pediatric research by the National Institutes of Health,” said David M. Rubin, MD, MSCE, a senior author of the study, attending pediatrician, and co-director of CHOP’s PolicyLab. “If a child is prescribed an antipsychotic, it’s important for doctors to inform parents and caregivers if the drug is being prescribed off-label, of potential side effects, and of counseling therapies that might be offered as an alternative to medication.”

The frequent off-label use of antipsychotics has raised concern among many health care providers, especially in light of evidence linking antipsychotics with an increased risk of serious metabolic side effects in children, including weight gain and diabetes. (emphasis mine)

The researchers note that the increase in antipsychotic use is due to in part to an overall increase in the number of mental health diagnoses assigned to children. Researchers found a 28 percent increase in the number of children with a mental health diagnosis, but this alone did not account for the spike in prescriptions.  read the rest here

Let's be real off label prescriptions for a class of drugs that are not very effective for the diagnosis of schizophrenia, the diagnosis the drugs were originally approved and prescribed for, have become the most prescribed drugs for children on Medicaid due to FRAUD and UNETHICAL medical practice, and because Medicaid is seen as a sure source of income by the corrupt drug companies...

< French neuroleptique, equivalent to neuro- neuro- +-leptique < Greek lēptikós disposed to take, equivalent to lēp- (verbid stem of lambánein to seize) + -tikos -tic;

So what we have is criminal medical professionals who have decided it's ok to give children drugs that seize the nerves and cause serious iatrogenic, i.e. physician caused, neurological and physiological impairments. We are being told that this has "raised concern" among professionals. Well it's done much more than raised my concern!  I am outraged. When are people going to wake up to the fact that statements like "it is reassuring that these drugs have been recognized as a priority for pediatric research by the National Institutes of Health" mean that the prescribing of the neuroleptic drugs off label is without any evidence to support it!!!!  and conducting drug trials to collect evidence to support what is being done in STANDARD PRACTICE is UNETHICAL and is backwards!!! Theoretically standards are derived from empirical evidence; in reality, they are  implemented by a vote and are without definitive empirical support of a drug's effectiveness or safety when prescribed off label to children.  

My son's childhood was ruined by these drugs, he is a Risperdal victim, who was a victim of violent crime, needed the recommended treatment for his PTSD and his BRAIN INJURY. Instead, he was drugged into a state of disability. Does that sound like evidence-based mental health care or a "best practice" to you? 

Let's be clear: the neuroleptic drugs cause more than metabolic issues; they cause brain damage, cardio-vascular damage, hormonal dysfunction, among other things.  Children have dropped dead as a result of psychiatry's Standard Practice of using teratogenic psychotropic drugs off label.  

Tuesday, August 14, 2012

thirteen

Bonkers Institute of Nearly Genuine Research

This summary, written by Jon McClellan is inaccurate from my perspective. Specifically, McClellan states,  "mostly we discussed how frustrating it is to have a son so sick, and also tried to validate her worries given there are significant concerns with his medications."  It is apparent to me that this arrogant prick had NO insight whatsoever into either my son or myself... What I understood was I had been on his ass for over three years by the time this review was held. I had been on his ass about the drugs which had never been helpful.


I had been on his ass about what in the hell he had been doing 
to my boy for almost three years when he wrote this!

This the first time the jerk put down in writing that I had "my concerns" about the drugs and the damage being inflicted on my son. This is how he characterized my loud at times rude, crude, and oft-repeated vehement objections to his abusive mis-treatment of my son. No sense of duty to obtain Informed Consent, or actually respect Isaac or myself.  McClellan needed no one's approval but his own. McClellan seems to have had no insight whatsoever into how his demeanor and his behavior made him seem untrustworthy, and disrespectful. He actually is stating that the fact my severely impaired son would take whatever was given to him, was a sufficient substitute for Informed Consent.  Incredibly, two psychiatrists in the community agreed--and they both used the same excuse as Jon McClellan. Since my brain damaged son was over thirteen, they didn't need my Informed Consent to continue to drug him without Informed Consent ever having occurred in the first place.

BTW that "current dose of Clozapine" had remained unchanged for over two years...the very maximum dose of 900 mgs a day. Currently, today this drug is still not approved for use in children under 16 years old for any purpose.

Thursday, July 5, 2012

It is fraud: it is Standard Practice

Big Pharma marketing. HG Wells: advertising is legalized lying. George Orwell: advertising is the rattling of a stick inside a swill bucket.
 bonkersinstitute.org

I am biased by my experiences with the publicly funded programs that serve foster children.  The system is a poor substitute for a family---my now adult sons and I are painfully aware of how publicly funded Child Welfare and Mental Health social service systems can become a family's worst nightmare.  I am grateful beyond measure that my family has come through some horrible experiences  intact.  That my son, Isaac, has survived at all, is a miracle many times over---We have been blessed; and I am so aware that not everyone is as lucky as we have been.  That fact has kept me awake more nights than I can possibly count... 



via Wikipedia:

In criminal law, a fraud is an intentional deception made for personal gain or to damage another individual; the related adjective is fraudulent. The specific legal definition varies by legal jurisdiction. Fraud is a crime, and also a civil law violation. Defrauding people or entities of money or valuables is a common purpose of fraud, but there have also been fraudulent "discoveries", e.g., in science, to gain prestige rather than immediate monetary gain. 


Most people would agree that people need to told accurate information about the validity of a diagnosis; including whether or not it is Biological in nature; or if this is a belief based on nothing more than a yet to be validated Hypothesis.  Saying that a psychiatric diagnosis is a disease/chemical imbalance/neuro-biological in nature is a story told to "bust the stigma" and to get people to take their meds; not because it is based on fact. 

Most people would agree that people need to given accurate, unbiased information about the drugs prescribed to them and their children.  Most of us would agree it would be wrong to tell people that they in fact have a disease/chemical imbalance or a neuro-biological condition requiring drugs to treat it; when no imbalance, disease, defect or neuro-biological condition has been identified.  These claims are being made without any physical, neurological or medical examination taking place.  A conversation with the person and gathering information from others about their personal opinions and subjective observation of the patient or 'client' is not an examination; and even a consensus of informed opinions does not make the weakest of 'evidence' scientific or valid; it does not make the psychiatric diagnosis a medical condition either.  


The fact is: no genetic condition, chemical imbalance, or neuro-biological pathology 
has ever been identified in any human being alive or dead; 
that causes any mental illness, or psychiatric diagnosis.

It is important you have accurate information about the risks, the negative effects of the drugs, including lethal risks; and are not simply given biased information about the potential benefits of taking a psychiatric drug. For professionals to ignore their ethical duty to fully inform patients and parents of children about the nature of psychiatric diagnoses, about the potential for harm involved in taking psychiatric drugs is criminal; not just "unethical."  It is, in reality fraud to state the drugs correct a dysfunction; since no physiological dysfunction has actually been identified.  To tell this lie, and then not fully inform people about the serious risks inherent in taking psychiatric drugs as prescribed, is medical consumer fraud.  Failing to give people the very information which is necessary to protect their children and themselves is particularly heinous; despicable really, all things considered.

Since no pathological finding has actually been identified, this particular hypothesis has never been validated.  It is not a valid scientific finding, or a medical disease; it is simply a ploy used to perpetrate fraud in medical practice.  It is used to manipulate and control by misinforming people with the intention of altering their beliefs and their behavior. i.e. to gain cooperation and to maintain 'treatment compliance.'   Told to family members this false claim is used in an effort to enlist their cooperation and participation in coercing a family member to be 'treatment compliant.' This being the case, it is an unethical claim for any psychiatrist or mental health professional to make.  It is dishonest, it is disrespectful and it is evidence of an utter lack of professional integrity.  How in the hell is this not recognized as a root cause of non-compliance, the source of the growing mistrust of psychiatry and the primary reason people have for avoiding psychiatric treatment?  Avoiding people who are dishonest, coercive and abusive is a natural healthy response for a reasonable person to have.

It is fraud to tell a story in order to alter other people's behavior.  People that believe this story pay for appointments, treatments and very expensive drugs; or are on public medical programs we all pay for.  Many believe the drugs are treating a disease, because of the erroneous belief that doctors don't lie to patients.  People take neurotoxic drugs believing that the drugs treat a brain disease they have.  The drugs cause iatrogenic, or 'physician caused' diseases, neurological impairments, and can disable them; and even cause their untimely death.  Many are never told the serious risks involved.

Not one of my once able-bodied and physically healthy friends who are now physically and /or cognitively impaired were informed of the well-documented common effects that have disabled them.  I was not told what could happen to my son by lead researcher who used him as a human guinea pig without consent, informed or otherwise.  Multiple neurotoxic drugs used concomitantly in doses and combinations which are contraindicated and not approved for pediatric use have a traumatic disabling effect on human beings.   Without proper medical help, how can I help my son recover?  The betrayal of trust and the trauma of having my son used in State sanctioned Drug Trials without my permission; in spite of my vehement protests.  I was prevented from protecting my own child from public 'servants' who abused their authority, committed perjury, felony assault and medical neglect in the process of drugging my son into a state of disability with unapproved unsafe neurotoxic drugs known to be particularly harmful to children.

It is fraud.  It is criminal, and it has been done by the eugenicists/psychiatrists and unethical professionals in this country to the 'genetically and/or socially inferior' for decades.  American psychiatrists with a notion of genetic superiority instituted a program of torture as treatment in psychiatric institutions as a social service project to cleanse the gene pool and protect their society from the psychiatric patients; victims they tortured, maimed, and killed.  These ideas and methods were used by German psychiatrists who later helped the Nazis effectively kill millions---pseudo-scientific, pseudo-medical treatment standards that originated here in America and have remained entrenched within standard psychiatric clinical practices and family and child welfare social service programs.  The bio-medical model was and is a means to segregate the 'seriously mentally ill' from the rest of society; "for the good of society."  It has never been an ethical medical treatment provided in the patient's best interest; psychiatric treatment is more often, something done to the patient supposedly for 'society's benefit.'

What was done to my precious son is not unique; it is a consequence of how bio-psychiatry  practices medicine through social engineering.  The willful blindness and hubris of arrogant psychiatrists who have deceived, defrauded, disabled and killed patients is only surpassed by those   psychiatrists and other medical professionals who fail to censure, and discredit the unethical methods used and the people who use them.  It is a passive aiding and abetting of criminal behavior, professionals who do not take a stand against such unethical and illegal behavior became complicit when remaining silent, failing to speak in defense of victims; or even offer them medical assistance.  The criminals are heralded as 'Lead Researchers' consulted by Public Policy Makers, enlisted as 'Scientific Advisers' and more than one of these thugs in white coats have been elected President of the APA.

I am utterly outraged by the lack of action to protect children on Medicaid; particularly those who are  foster children.  The plan is to monitor the ongoing off label drugging which is defrauding Medicaid!  The plan in effect, is to continue to use foster children as human guinea pigs because the ADULTS don't want to be responsible, to DO THE RIGHT THING and to STOP using them as guinea pigs in  Human Experimentation.  It is a gross misstatement to imply that the use of psychiatric drugs is  Evidence Based Medicine; much less imply that prescribing these teratogens recklessly could possibly be in any child's best interest.  I saw no evidence that foster children's fundamental needs, particularly the need to be protected from further harm, was a primary concern ---or even seriously considered in the development of the recommendations for change in "Interstate variation in trends of psychotropic medication use among Medicaid-enrolled children in foster care" published in Children and Youth Services Review.  here  The press release announcing this report hailed it as laying the foundation for the necessary changes needed to better serve foster children, I call that claim an exaggeration. 

The plan is to continue allowing foster children, to be used as guinea pigs.  Continue to conduct seeding trials in an attempt to garner FDA approval for drugs currently used off-label, with ill effect.  Off-label prescriptions without valid evidence of safety or effectiveness for the reason they are prescribed is Human Experimentation, calling it 'off-label' prescribing sure makes it sound innocuous doesn't it?

It is fraud.  
  It is Standard Practice. 
It is criminal. 

Moral: Drugging foster children using diagnostic criteria and treatment protocols based on subjective opinions is acceptable if it facilitates defrauding Medicaid and it enables BigPharma to meet it's marketing goals of increasing already obscene profit margins. Poor children on Medicaid and in foster care are simply a means to an end to exploit; an expendable commodity. 


originally posted 5-11-2012 rewritten 7-5-20112

Sunday, February 5, 2012

Controversies Surrounding the Pediatric Bipolar Diagnosis & Treatment


via The Hastings Center:

Controversies Surrounding the Pediatric Bipolar Diagnosis & Treatment (Bioethics Briefs)

Wednesday, October 12, 2011

The evidence regarding psychotropic drugs


via Heart & Soul of Change Project


Can’t Make It Up This Good–or Bad: TEOSS Follow-Up

Dr. Barry Duncan
Sometimes, people don’t believe me when I talk about the evidence regarding psychotropic drugs. It does sound far-fetched some times because the evidence is so much different than what you hear in everyday conversation.  The difference between what you hear or read in the media and the clinical trial data is striking, so much so that reporting the real evidence often leads to raised eyebrows. But you know, I couldn’t make it up near as well or as damning as the actual clinical trial evidence. For example consider the latest about antipsychotics and kids.

Prescriptions for antipsychotics for children continue to skyrocket, despite underwhelming evidence. Here is how we wrote about the NIMH funded Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (Sikich et al., 2008) in our recent chapter in the Heart and Soul of Change, 2nd Edition (Sparks, Duncan, Cohen, & Antonuccio, 2010):

“Described as a landmark trial (McClellan et al., 2007), TEOSS sought to examine the efficacy, tolerability, and safety of two second generation antipsychotics (SGAs; Risperdal and Zyprexa) for youths diagnosed with early-onset schizophrenia spectrum disorder and to compare these to a first generation antipsychotic FGA (molindone or Moban). Fewer than 50% of subjects completed 8 weeks of treatment and response rates were low and not significantly different for all three groups (Sikich et al.). Participants in the study were allowed concomitant use of antidepressants, anticonvulsants, and benzodiazepines, compromising even these disappointing findings. A 17-year old boy committed suicide and an unspecified number of participants were hospitalized due to suicidality or worsening psychosis. These events are particularly disturbing in light of the fact that youths considered at risk for suicide were excluded from the study. Weight gain was deemed serious enough to warrant suspension of the Zyprexa arm (McClellan et al.).”

It gets better or should I say worse? Follow up, available on line and soon to be published in the June issue ofJournal of the American Academy of Child & Adolescent Psychiatry (see the abstract at http://www.jaacap.com/article/S0890-8567(10)00294-7/abstract, revealed that only 14 of the 116 youth (12%) responded to the medication and stayed on it for one year. That’s right, you read it correctly–12%! Recall that in the famous adult trial of antipsychotics (the CATIE trial) that 74% dropped out. So it is even worse in youth—88% failed to benefit.

So let’s break this down. First, TEOSS was not placebo-controlled. The 116 youth enrolled into the trial were randomized either to a first generation antipsychotic (Moban) or to an atypical antipsychotic or so called second generation antipsychotic (Risperdal and Zyprexa). At the end of eight weeks, the response rate was 50% for those treated with Moban, 46% for Risperdal, and 34% for Zyprexa. Adverse events were “frequent” in all three groups.

Only those youth who “responded” during the initial eight weeks — 54 of the 116 — were entered into the 44-week maintenance study. Forty of the 54 youth dropped out during this period because of “adverse effects” or “inadequate response.” Thus, only 14 of the 116 youth who entered the study responded to the medication and stayed on it for as long as one year—only 12%.

Pharmacotherapy helps some children and adolescents, although apparently not very many. However, the preponderance of empirical research indicates that the risk may not be worth it. While pharmacotherapy involves considerable risk for young people, psychosocial interventions have a strong track record with virtually no adverse associated medical events. APA’s Working Group on Kids and Psychotropics (2006) concluded:

For most of the disorders reviewed herein, there are psychosocial treatments that are solidly grounded in empirical support as stand-alone treatments. Moreover, the preponderance of available evidence indicates that psychosocial treatments are safer than psychoactive medications. Thus, it is our recommendation that in most cases, psychosocial interventions be considered first. (p. 16. Italics added)

As the evidence regarding TEOSS suggests, the automatic prescription of antipsychotics for sure, but with any psychotropic, is unwarranted. Where children are concerned, the stakes are higher. They are, essentially, mandated clients—most do not have a voice to say no to treatments or devise their own, and depend on adults to safeguard their wellbeing (Sparks & Duncan, 2008). If you are seeing kids taking antipsychotics, you are on very firm ground to raise concerns and ensure the treatment is fitting client preferences.

Sunday, January 9, 2011

Conflicts of Interest are Real

The following is from the Alliance for Human Research Protection, whose mission statement on their website states:

"The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected" 

Conflicts of Interest in Clinical Trials
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by
The U.S. Army Medical Department
and
The Henry M. Jackson Foundation for the Advancement of Military Medicine

May 5-7, 2002



Case 7: Children exposed to risks in psychotropic drug trials:
Psychotropic drugs are being tested in children despite the acknowledged risks of harm. Psychotropic drugs are advertised as normalizing a "chemical imbalance" in the brain. In fact, they do the opposite: they induce profound changes in the central nervous system with demonstrable physical and neurological impairments.[48] Dr. Steven Hyman, former director of NIMH, an expert on the mechanisms by which psychoactive drugs work, explained that, whether abused or prescribed, the mechanisms by which psychoactive drugs work are the same.[49] Hyman stated that antidepressants, psychostimulants, and anti-psychotics created "perturbations in neurotransmitter function."[50] The drugs' severe adverse side effects are symptoms of the drugs' disruptive effect on the neurotransmitter system and on brain function.

In 2001 Dr. Benedetto Vitiello, NIMH's director of Child and Adolescent Treatment and Preventive Interventions Branch acknowledged the impact of FDAMA: "pediatric psychopharmacology has recently seen an unprecedented expansionclinical trials in youths has more than doubled in the last few years."[51] Indeed, children as young as three are being recruited to test mind-altering drugs that may affect their developing brain. Parents are being offered financial inducements to volunteer their children for drug trials. The foremost problem with prescribing or testing psychotropic drugs for children is the absence of any objective criteria for diagnosing children with pathological behavioral problems to justify pharmacologic intervention. Vitiello acknowledged "diagnostic uncertainty surrounding most manifestations of psychopathology in early childhood."[52] Vitiello also acknowledged the possibility of long-term harm: "The impact of psychotropics on the developing brain is largely unknown, and possible long-term effects of early exposure to these drugs have not been investigated."

Eli Lilly's highly touted new anti-psychotic, Zyprexa,[53] reveals much about the collision between corporate interests and the health and safety of children. In clinical trials averaging 6 weeks, Zyprexa was tested in 2,500 adults. The drug was linked to serious, in some cases life-threatening side effects requiring hospitalization in 22% of those tested.[24]Acute weight gain of 50 to 70 lbs is usual, and with it the increased risk of diabetes. FDA data (under FOIA) reveals a 65% drop out rate, and only 26% favorable response. During those 6 week clinical trials there were 20 deaths, of which 12 were suicides.[54] David Healy, who found a suicidal link to antidepressants (Selective Serotonin Re-uptake Inhibitors) in his research says, as far as he can establish, the data from these trials "demonstrate a higher death rate on Zyprexa than on any other antipsychotic ever recorded." [55] In 2000, FDA approved Zyprexa for short- term use only, in bi-polar patients. [56]

Yet, children aged six to eleven were recruited for clinical trials to test the drug. According to their published report, UCLA investigators tested Zyprexa on children who were not even diagnosed as having schizophrenia. The children were diagnosed as having a variety of questionable psychiatric disorders, including ADHD.[57] According to the published report, all the children in the trial experienced adverse effects, including sedation, acute weight gain, and akathisia (restless agitation). The trial was terminated less than six weeks after it had begun.

Controversy surrounds a Zyprexa trial at Yale University. In that experiment, 31 youngsters aged 12 to 25 who have not been diagnosed with any psychiatric illness are being exposed to the drug for one year. The stated rationale given by the researchers (who are under contract with the sponsor) is their speculation that these children may be "at risk" for schizophrenia. Since there are, as yet, no objective tests or biological markers for the illness - they hypothesize without evidence, merely on the basis of conjecture. The shaky basis for their conjecture is that assumption that the children may develop schizophrenia because one of their siblings has been diagnosed with the disorder.

The risk of schizophrenia for the general population is 1%. For siblings the risk increases from 2% to 15% - in other words there is 85% likelihood that these children will never develop schizophrenia.

Given the absence of scientifically accurate tools for interpreting psychiatric symptoms, psychiatrists cannot as yet accurately diagnose schizophrenia much less predict which children will get it. Is it ethical to expose healthy children to risks of drug- induced pathology on such speculation? The Wall Street Journal aptly noted that such a study "raises the question of whether the drug companies are mainly interested in "creating" a new illness that requires drug treatment." Read the entire report here

Here is another Report from Alliance for Human Research Protection:
State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, including an antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them. 

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.

Write to David Armstrong at david.armstrong@wsj.com
Printed in The Wall Street Journal, page B1                                                    Complete article here
Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

It is obvious to me the informed consent guidelines for foster kids in Washington State primarily protect the State of Washington; not the children in State care.  Let's be real, who in their right mind would believe that it is in the "best interests" of the children and teenagers in Washington State to lower the legal age of consent for psychiatric treatment to thirteen?  Human's brains are not fully fully mature,until we are in our early 20's. Couple this reality with the dishonesty, abuse of authority and of "Medical" privilege that psychiatry is known to rely upon in standard clinical practice; we have in effect, "legally" placed kids in harm's way. 


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